News Hub | News Direct

Healthcare

Addiction Biotech Cannabis Genetics Healthcare Medical Devices Pharmaceutical Science Veterinary
Article thumbnail News Release

The Future of Stem Cell Investing: Spotlight on Smaller Innovators

ADIA BLUE CRSP MESO

The global stem cell therapy market is entering an era of unprecedented growth and innovation. Valued at $5.13 billion in 2024, the U.S. stem cell market alone is projected to reach $15.79 billion by 2034, growing at a compound annual growth rate (CAGR) of 11.9%. Globally, the market is expected to hit $28.89 billion by 2030, fueled by advancements in regenerative medicine, increased government funding for research, and the development of groundbreaking therapies for conditions like cancer, autoimmune diseases, and genetic disorders. Stem cells, often called the body’s internal repair system, have the unique ability to divide and regenerate, offering hope for treatments that address the root causes of diseases rather than just managing symptoms. From repairing damaged tissues to regenerating organs, the potential applications of stem cell therapies are vast and transformative. The U.S. Food and Drug Administration (FDA) has already approved several stem cell-based treatments, and the pipeline of new therapies continues to expand. This rapid growth is driven by several key factors: the rise of stem cell banks, increasing therapeutic potential, and a surge in research aimed at developing regenerative medicines. While large pharmaceutical companies and research institutions play a significant role, smaller biotech firms are also making important contributions, pushing the boundaries of what’s possible in this dynamic field. In this piece, we explore some of the companies making waves in this exciting and rapidly evolving sector, highlighting their achievements, challenges, and potential to shape the future of medicine. ADIA Nutrition Inc. (OTC: ADIA) is on a mission to transform healthcare through innovation in regenerative medicine and premium organic supplements. Operating under two key divisions—its supplement arm and Adia Med, its medical division—the company is making waves in the fast growing global stem cell market. With cutting-edge therapies like Umbilical Cord Stem Cells (UCB-SC) and Autologous Hematopoietic Stem Cell Transplantation (aHSCT), ADIA Nutrition is empowering patients to address conditions ranging from autoimmune disorders to orthopedic injuries. 2025 has been a landmark year for ADIA Nutrition, with groundbreaking achievements that emphasize innovation and accessibility. In March, the company celebrated the FDA registration of Adia Vita, its premier stem cell product. This allows Adia Vita to be distributed nationwide, significantly expanding access to regenerative medicine. "This acceptance reflects Adia Labs' commitment to broadening access," said Larry Powalisz, CEO of ADIA Nutrition. The registration enhances patient access and opens new revenue opportunities. In February, ADIA announced a strategic expansion plan by partnering with elite Medical Spas to create satellite locations across the U.S. This low-cost model will offer treatments like UCB-SC therapies and stem cell injectables to health-conscious regions, tapping into an existing customer base and creating revenue streams via service fees, royalties, and equity interests. "This expansion is a testament to our commitment to making therapies more accessible," Powalisz said. The launch of Adia Labs LLC in February solidified ADIA’s leadership in regenerative medicine. Adia Labs introduced AdiaVita, a high-potency stem cell product containing 100 million cells and 3 trillion exosomes per dose, designed for clinical research and therapeutic use. A future product, AdiaLink, will contain 3.5 trillion exosomes, pushing the boundaries of medical science. "We are advancing medical science while maintaining the highest standards of safety and quality," Powalisz stated. A key to ADIA’s success is its partnership with a premier FDA-approved laboratory, ensuring the highest quality stem cell and exosome products. Each dose is third-party verified for purity, potency, and safety, making it a trusted choice for medical professionals. "After months of due diligence, we offer the best quality therapies per treatment," Powalisz noted. This partnership guarantees a steady supply of top-tier products. ADIA is also working to secure private insurance coverage for treatments like aHSCT and injectable stem cells, reducing the financial burden on patients and expanding access. "Registering with the AHCA is a monumental step in providing open access to our therapies," Powalisz said. The company’s integration into the mainstream healthcare ecosystem is gaining traction, with several patients already preapproved by private insurers. The Winter Park, Florida clinic has exceeded financial expectations in its first month of operation, offering FDA-compliant treatments for conditions like Multiple Sclerosis, hip issues, and joint pain. "Many patients have traveled abroad for treatments we now offer locally," said Dr. Monica Sher, Chief Stem Cell Medical Officer at Adia Med. Looking ahead, ADIA plans to replicate its successful clinic model in new markets, expand satellite locations, and complete its uplisting to the OTCQB Venture Market. With aspirations for a Nasdaq listing, the company could be poised for significant growth. "From January's financial win to February's breakthroughs, we’re redefining healthcare possibilities," Powalisz added. "We’re committed to innovation and sustainable growth." For investors, ADIA offers a unique opportunity to be part of a company revolutionizing healthcare. With its innovative treatments, strategic partnerships, and commitment to quality, ADIA Nutrition is well-positioned to lead the regenerative medicine industry. CRISPR Therapeutics (NASDAQ: CRSP) is a biotechnology company that uses the CRISPR/Cas9 gene-editing tool to develop treatments for serious diseases. This powerful technology, which won a Nobel Prize, enables scientists to modify faulty genes that cause a variety of illnesses. The company made a major breakthrough in late 2023 when its first product, CASGEVY, became the first-ever CRISPR-based therapy to gain FDA approval. CASGEVY targets two blood disorders—sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)—by utilizing stem cells, marking a significant milestone in the practical application of gene editing. The launch of CASGEVY has been progressing well. By the end of 2024, over 50 treatment centers globally were set up to administer the therapy, and more than 50 patients had already begun the treatment process. The company anticipates further growth in patient enrollment in 2025, with clinical trials for children aged 5 to 11 now completed, with results expected later this year. In addition to CASGEVY, CRISPR Therapeutics is exploring ways to improve stem cell therapies, including developing methods that avoid the need for intensive pre-treatment steps. While the company is initially known for its blood disorder treatments, CRISPR Therapeutics is expanding its focus to other areas, such as cancer and autoimmune diseases. One promising program is CTX112, an advanced CAR T-cell therapy that uses modified immune cells to fight blood cancers. Early results from clinical trials have been promising, and the FDA has granted CTX112 a special designation to expedite its development. Updates on CTX112’s progress are expected in mid-2025. CRISPR is also investigating the potential of CTX112 in treating autoimmune diseases, such as lupus, with more data anticipated in the coming months. CRISPR Therapeutics (NASDAQ: CRSP) is also looking into regenerative medicine, with one of its key initiatives, CTX211, aiming to treat Type 1 diabetes using stem cells. The goal is to enable patients to produce their own insulin, potentially eliminating the need for daily injections or long-term medication. Additional information on this program is expected in 2025. Financially, CRISPR Therapeutics is in a strong position, with approximately $1.9 billion in cash, providing a solid foundation for continued research and development. While CASGEVY’s sales may face slow growth due to the complex nature of the treatment process, the company remains focused on long-term goals, developing transformative therapies that could significantly impact patients’ lives. Despite challenges in the stock market, many analysts maintain an optimistic outlook for CRISPR Therapeutics. Some predict a potential 87% increase in its stock price within the next 12 months, especially if upcoming clinical trial results prove positive. With its innovative technology, diverse therapeutic pipeline, and solid financial backing, CRISPR Therapeutics (NASDAQ: CRSP) is well-positioned to remain a leader in gene editing and stem cell therapies. Mesoblast Limited (NASDAQ: MESO) is a biotech company focused on developing stem cell-based treatments for severe inflammatory diseases. One of its major advancements is RYONCIL, a mesenchymal stromal cell (MSC) therapy that received FDA approval in December 2024. RYONCIL is designed to treat steroid-refractory acute graft-versus-host disease (SR-aGvHD), a life-threatening condition in which a patient's immune system attacks the body after a bone marrow transplant. In clinical trials, RYONCIL demonstrated a 70% response rate, with 49% of patients surviving for four years. The therapy is priced at $194,000 per infusion and is available through Mesoblast’s MyMesoblast patient services hub, with distribution managed by Cencora. Mesoblast is also expanding the use of its stem cell technology for other conditions. The company is testing RYONCIL in pediatric patients with Crohn’s disease, a severe inflammatory bowel disease. Early studies in adults have shown promising results, and Mesoblast plans to extend testing to children who have not responded to other treatments. Additionally, Mesoblast is developing REVASCOR, a stem cell therapy aimed at treating heart failure. In 2024, the FDA supported an accelerated approval pathway for REVASCOR in patients with end-stage heart failure who rely on mechanical heart pumps. Mesoblast is also researching REVASCOR for children with hypoplastic left heart syndrome (HLHS), a rare heart condition, which could open the door to further FDA approvals. On the financial front, Mesoblast is in a relatively strong position. The company raised $161 million in a private placement, leaving it with approximately $200 million in cash to support its ongoing research and development activities. Mesoblast has also reduced its operating expenses by 22% from the previous year, indicating improved financial management. With the FDA-approved RYONCIL and a pipeline of other promising therapies, Mesoblast appears positioned to continue its work in stem cell-based treatments. bluebird bio, Inc. (NASDAQ: BLUE), founded in 2010, has been a significant player in the field of gene therapy, focusing on developing treatments for severe genetic diseases like sickle cell disease, β-thalassemia, and cerebral adrenoleukodystrophy. Over the years, the company has received FDA approvals for three gene therapies, positioning itself as a leader in the space. However, despite its scientific accomplishments, bluebird bio has faced substantial financial challenges, leading to its decision to go private in 2025. In early 2025, bluebird bio announced an agreement to be acquired by global investment firms Carlyle Group Inc. and SK Capital Partners, along with a team of biotech executives. Under the terms of the deal, bluebird bio’s stockholders will receive $3.00 per share in cash, with the potential for additional payouts of up to $9.84 per share through a contingent value right, depending on the performance of its product portfolio. The acquisition, expected to close in the first half of 2025, will provide bluebird bio with the capital needed to scale the commercial delivery of its gene therapies. "For more than a decade, bluebird has been at the forefront of gene therapy, delivering treatments to patients facing life-threatening genetic diseases," said Andrew Obenshain, CEO of bluebird bio. "However, as financial challenges mounted, it became clear that securing the right strategic partner was critical to maximizing value for our stockholders and ensuring the long-term future of our therapies." The acquisition arrives at a difficult time for bluebird bio. The company has faced mounting financial pressures, including the denial of a priority review voucher by the FDA and the risk of loan default. By partnering with Carlyle and SK Capital, bluebird bio aims to secure the necessary resources to continue its operations and bring its therapies to patients. Upon completion of the deal, bluebird bio will no longer be publicly traded, and former Mirati Therapeutics CEO David Meek is expected to take over as the new CEO. bluebird bio has achieved notable scientific milestones, particularly with its LYFGENIA (lovotibeglogene autotemcel, or lovo-cel) gene therapy for sickle cell disease. At the 66th American Society of Hematology (ASH) Annual Meeting in December 2024, the company presented long-term data showing that LYFGENIA significantly reduces or eliminates vaso-occlusive events (VOEs) in patients with sickle cell disease. Among the 58 patients treated in the HGB-206 and HGB-210 studies, 94.7% achieved complete resolution of severe VOEs, with benefits sustained for a median of over four years. Notably, patients with a history of overt stroke, a severe complication of sickle cell disease, remained stable without recurrent strokes for up to nine years post-treatment. These results highlight the therapy's potential to address the underlying cause of the disease. Despite these scientific successes, bluebird bio’s financial struggles highlight the challenges of commercializing high-cost gene therapies, particularly in a complex reimbursement environment. The decision to go private reflects the difficulties in balancing innovation with financial sustainability. While its shares will soon be removed from public trading, bluebird bio’s contributions to the field of gene therapy remain significant. Its therapies have provided new treatment options for patients with severe genetic conditions, and its ongoing research continues to advance gene therapy science. As the company transitions to private ownership, its focus on delivering innovative treatments to patients will remain central to its mission. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by ADIA Nutrition Inc. to assist in the production and distribution of this content related to ADIA. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com

March 04, 2025 07:00 AM Eastern Standard Time

Article thumbnail News Release

ASSOCIATION OF PICKLEBALL PLAYERS ANNOUNCES APP NATIONAL PICKLEBALL CHALLENGE SUPPORTING THE AMERICAN CANCER SOCIETY

Association of Pickleball Players

The Association of Pickleball Players (APP) and the American Cancer Society will join forces during National Pickleball Month this April to launch the APP National Pickleball Challenge, a nationwide initiative designed to support people facing cancer and build healthier communities. The APP National Pickleball Challenge tasks participants to play pickleball ten times during the month and track their active minutes, competing for a spot atop the national leaderboard. Whether it’s playing a competitive match, enjoying a casual match with friends, cardio training, or bouncing a ball up and down on a paddle, any pickleball-related activity will count towards the challenge. Players can register and start fundraising today on JustGiving and will start tracking their pickleball activity on April 1 via the Stridekick mobile application or manually. “We are excited to work with the American Cancer Society to continue to use pickleball for good,” said Shannon Dan, APP EVP of Strategy and Growth. “By participating in this challenge, you can play the sport you love, reduce your personal cancer risk by staying active, and support people facing cancer. It’s such a fun, easy way to make a difference!” One hundred percent of the proceeds raised during the APP National Pickleball Challenge will directly benefit the American Cancer Society and their mission through funding cancer research discoveries, enhancing direct patient support in 20,000 communities across the country and through advocating for policies that enhance access to cancer care. How It Works Sign Up: Beginning Wednesday, Feb. 26, register for the APP National Pickleball Challenge on JustGiving. Start fundraising! All challengers that generate $25 in donations will receive a free “Strength & Hope” t-shirt from the American Cancer Society and the top ten fundraisers will receive a revolutionary OWL Sport paddle from the APP! Grab your paddle and get moving! Once the challenge is live, you can easily track your activity and compete with friends using the Stridekick mobile app. It even allows you to connect your fitness tracker and work your way up the national leaderboard for active minutes. Spread the word about the APP National Pickleball Challenge and share updates on your progress throughout the month on social media to spark more donations! The American Cancer Society is a leading cancer-fighting organization with a vision to end cancer as we know it, for everyone. For more than 110 years, the organization has been improving the lives of people with cancer and their families as the only organization combating cancer through advocacy, research, and patient support. To learn more about the APP National Pickleball Challenge and support the American Cancer Society, visit cancer.org. The pickleball community can stay in the know on the latest APP updates at theapp.global, and by following the APP’s Instagram, X, Threads, TikTok, Facebook and LinkedIn channels. The Association of Pickleball Players (APP) provides opportunities for pickleball players of all ages and skill levels—professionals, amateurs and recreational—to compete in world-class pickleball events for the opportunity to win prize money and be featured on nationally televised broadcasts on CBS Sports and ESPN. Since its launch in 2019, the APP has operated the first and only pro and amateur pickleball tour fully and officially sanctioned by USA Pickleball. The APP opened its official headquarters and player development center in January 2025 at The Fort in Fort Lauderdale, Fla., while its corporate offices continue to be located in Chicago. The APP Tour’s 2025 schedule will feature the most robust pickleball showcase across pro and amateur competitions accompanied by youth development programs, grassroots charity initiatives and international partnerships to continue to grow the game. Schedules, recent news and additional information about the APP are available at theapp.global and on Instagram, X, Threads, TikTok, Facebook and LinkedIn. Contact Details Daniel Sagerman +1 847-800-8182 dsagerman@theapp.global Company Website https://www.theapp.global

February 27, 2025 12:00 PM Eastern Standard Time

Article thumbnail News Release

Spin-Offs: Potential Catalysts for Big Gains

OSTX MMM K GE

Spin-offs can be powerful catalysts for unlocking shareholder value by transforming distinct business units into standalone entities. This separation often creates growth opportunities and attracts investor interest, potentially leading to significant price gains and the allure of stock dividends. Let’s explore recent examples of completed spin-offs, examine how they have shaped the market, and highlight a potential opportunity to keep an eye on. OS Therapies, Inc. (NYSE-A: OSTX), a clinical-stage biotechnology company focused on innovative cancer treatments, recently announced a strategic move that could significantly enhance shareholder value: the formation of its subsidiary, OS Drug Conjugates (OSDC), and plans to spin off joint ventures (JVs) into standalone public companies. This initiative, coupled with the potential for stock dividends, has, in some cases, driven increased investor interest and share price appreciation, making OSTX a compelling opportunity. On February 20, 2025, OS Therapies unveiled its plan to spin off its next-generation tunable Antibody Drug Conjugate (tADC) and tunable Drug Conjugate (tDC) platforms into standalone entities through JVs with clinical-stage ADC therapeutics companies. These platforms, which use proprietary silicon-based linkers (SiLinkers™) to deliver targeted cancer therapies, are part of a rapidly growing market projected to reach $47 billion by 2029. The company intends to distribute stock dividends of these public JVs to shareholders, a move that could unlock hidden value and provide investors with direct exposure to high-growth segments. Spin-offs often create value by allowing investors to more clearly evaluate the worth of distinct business units. In OS Therapies’ case, the tADC and tDC platforms represent cutting-edge technology with significant potential in oncology. By spinning off these assets into standalone entities, OS Therapies could attract specialized investors and partnerships, further accelerating development and commercialization. Additionally, the spin-off dividend structure provides shareholders with tangible returns, enhancing the appeal of OSTX as an investment. While the spin-off is a key catalyst, OS Therapies’ core value driver remains its lead asset, OST-HER2, an immunotherapy targeting HER2-positive cancers. The company recently reported positive Phase 2b trial results for OST-HER2 in recurrent osteosarcoma, achieving its primary endpoint with statistical significance. The data showed: 33% of OST-HER2 patients were responders vs. 11% in the matched historical control group. 91% survival rate at 12 months vs. 80% in the control group. A strong safety profile supporting regulatory approval. OS Therapies is preparing to submit a Biologics Licensing Application (BLA) to the FDA in 2025, with potential approval by late 2025. If approved, OST-HER2 would be the first new treatment for osteosarcoma in over 40 years, addressing a $500 million market opportunity. The company also stands to receive a Priority Review Voucher (PRV), which it could sell for an estimated $150 million, providing non-dilutive capital to fund further development. OS Therapies is well-capitalized, with a $13.1 million cash position following a recent financing round. The company has also acquired new clinical assets to expand its pipeline, further solidifying its position in the oncology space. With a strong financial position, innovative technology platforms, and a clear path to market, OSTX presents a unique investment opportunity in the rapidly growing oncology sector. General Electric (NYSE: GE), a storied industrial conglomerate, made headlines on April 2, 2024, when it completed the tax-free spin-off of its power business into GE Vernova (GEV). Investors received 1 share of GEV for every 4 shares of GE owned, a move that has since proven to be a significant value driver for shareholders. Since the spin-off, GEV has performed remarkably well, opening at $142.85, briefly selling off, and then rallying to trade above $160 per share. With a market cap of $47 billion and an enterprise value of $41 billion, GE Vernova is now a standalone leader in the global energy sector. The spin-off allowed the market to focus on the growth potential of GE Vernova’s three core segments: Power (55% of revenue), Wind (22% of revenue), and Electrification (23% of revenue). The Electrification segment, in particular, has emerged as a standout, with a growing backlog and expanding margins driven by volume and price increases. This segment is expected to deliver strong revenue growth and continued margin expansion beyond 2024, supported by operational improvements and increasing demand for grid solutions. The Wind segment, while showing improvement in 2024, faces challenges such as lower equipment orders and EBITDA losses in Offshore Winds. Meanwhile, the Power segment remains resilient but may struggle to match the growth trajectory of Electrification. Despite these mixed dynamics, GE Vernova’s diversified portfolio positions it well to capitalize on the global energy transition. GE Vernova’s mission—embedded in its name—reflects its commitment to innovation and sustainability. The “GE” legacy signifies quality and ingenuity, while “Vernova” (from “verde” and “nova”) underscores its focus on a new era of lower-carbon energy. The company is uniquely positioned to benefit from the increasing demand for power generation and grid electrification, particularly in the U.S., where infrastructure investments are accelerating. Management expects GE Vernova to generate $36 billion in revenue in 2025, with $1.5 billion in free cash flow. These projections highlight the company’s strong financial foundation and its ability to deliver value to shareholders. Since its debut, GE Vernova has defied initial skepticism, rallying above $160 per share after opening at $142.85. This performance underscores the market’s confidence in the spin-off’s potential to create value. Historically, spin-offs like GEV have driven aggressive price gains as investors gain clarity on the standalone business’s growth prospects and financials. GE Vernova’s early success suggests it could follow a similar trajectory, particularly as it leverages its leadership in electrification and power generation. 3M (NYSE: MMM), the global science and innovation company behind iconic brands like Post-it notes, Scotch tape, and Thinsulate insulation, has been on a transformative journey. On April 1, 2024, 3M completed the tax-free spin-off of its healthcare division into Solventum (SOLV), a standalone company focused on advancing healthcare through breakthrough solutions at the intersection of health, material, and data science. Investors received 1 share of Solventum for every 4 shares of 3M owned, and the spin-off has been a significant catalyst for 3M’s stock, which has surged 89.3% over the past year, far outpacing the S&P 500’s 34.8% return. The spin-off allows 3M to focus on its core industrial and consumer products businesses, which include a diverse portfolio of over 55,000 products. By separating its healthcare division, 3M has unlocked value for shareholders, enabling both companies to pursue their distinct growth strategies. Solventum, now a standalone entity, specializes in products that treat and prevent infections, dental filling materials, and filtration and purification systems. The new company is well-positioned to capitalize on the growing demand for innovative healthcare solutions, while 3M can concentrate on driving innovation in its industrial and consumer segments. 3M retained a 19.9% stake in Solventum but plans to divest its remaining shares within five years, providing additional liquidity and potential upside for shareholders. The spin-off was structured as a tax-free transaction, further enhancing its appeal to investors. Additionally, 3M recently reached a significant milestone with the approval of its $10.3 billion settlement related to “forever chemicals” (PFAS) litigation. This resolution removes a major overhang for the company and provides greater clarity for its future growth trajectory. Since its debut, Solventum has entered the S&P 500 and begun trading on the New York Stock Exchange, reflecting its strong market position and growth potential. The company’s focus on enabling better, smarter, and safer healthcare aligns with global trends toward improved patient outcomes and more efficient healthcare systems. The spin-off of Solventum has been a win-win for 3M and its shareholders. By unlocking the value of its healthcare division, 3M has streamlined its operations and positioned itself for sustained growth in its core markets. Meanwhile, Solventum’s focus on healthcare innovation offers significant upside potential. Together, these developments have driven 3M’s stock to impressive gains, making it a standout example of how spin-offs can create value for investors. Kellanova (NYSE: K) completed a major restructuring, spinning off its North American cereal business into a new entity named WK Kellogg Co (NYSE: KLG) last year. This move created two independent, publicly traded companies: Kellanova (K) on the New York Stock Exchange, which focuses on global snacking, international cereal and noodles, and North American frozen foods, and WK Kellogg Co (KLG), also trading on the New York Stock Exchange, which concentrates on ready-to-eat cereals in the U.S., Canada, and the Caribbean. Shareholders of the original Kellogg Company received 1 share of WK Kellogg Co for every 4 shares of Kellanova common stock they owned, marking the beginning of a new chapter for both companies. Kellanova, which retained the iconic ticker symbol “K,” is now a pure-play snacking powerhouse with a portfolio of beloved brands like Pringles, Cheez-Its, Rice Krispies Treats, and more. The spin-off allows Kellanova to focus on its core strengths in the global snacking market, which is growing rapidly as consumer preferences shift toward convenient, on-the-go foods.” WK Kellogg Co, is now dedicated to revitalizing its North American cereal business, a segment that has faced challenges in recent years due to changing breakfast habits and increased competition. By separating the cereal business, both companies can operate more efficiently and pursue tailored growth strategies. Following the spin-off, both Kellanova and WK Kellogg Co experienced initial declines in their stock prices, with Kellanova falling over 7% and WK Kellogg Co dropping about 5% on the first day of trading. However, the long-term success of each company will depend on their ability to execute their respective strategies and adapt to evolving market conditions. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by O S Therapies Inc to assist in the production and distribution of content related to OSTX. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 mark@razorpitch.com

February 27, 2025 07:00 AM Eastern Standard Time

Article thumbnail News Release

Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment

NLS Pharmaceutics

NLS Pharmaceutics Ltd. (Nasdaq: NLSP”) (“NLS”) and Kadimastem Ltd. (“Kadimastem”), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes, in collaboration with iTolerance Inc. (“iTolerance”), a U.S. based regenerative medicine company, announced today the result from the Type B pre-IND meeting held by Kadimastem and iTolerance with a committee of the U.S Food and Drug Administration (“FDA”) on February 24, 2025, regarding the development of iTOL-102, a potential cure for diabetes that would not require life-long chronic immune system suppression. iTOL-102 is an investigational biologic for the treatment and potential cure of Type 1 Diabetes consisting of Kadimastem’s allogenic human stem cell-derived pancreatic islets (IsletRx cells) combined with iTolerance’s immunomodulator (iTOL-100). Kadimastem and iTolerance believe that the completion of the pre-IND meeting is a significant milestone toward the clinical development of iTOL-102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by grants received from the Israel-U.S. Binational Industrial Research and Development Foundation. iTOL-102 was evaluated at the fast-track center for testing at the Diabetes Research Institute (“DRI”) at the University of Miami School of Medicine, where it was designated as a potential breakthrough transplantation approach for the treatment of Type 1 Diabetes, as the novel combination of tolerance-inducing agent and human stem cell-derived islets. iTOL-102 demonstrated functional insulin release and disease reversal in an animal model, with full compatibility between IsletRx cells and iTOL-100. Prior to the meeting with the FDA, Kadimastem and iTolerance received a preliminary response document from the FDA, providing critical feedback on their current preclinical and clinical development plans. This guidance is instrumental in moving forward with the next stages of development. Based on the feedback provided at the pre-IND meeting, Kadimastem and iTolerance are now updating their plans for a safety toxicology study and the preparation of a First-in-Human clinical trial. Kadimastem believes its collaboration with iTolerance signifies a potentially transformative step in diabetes treatment, paving the way towards the potential development of iTOL-100 and requesting regulatory approvals for commercialization of a potential cure for type 1 diabetes. iTOL-100 is an immunomodulatory microgel technology being developed by iTolerance designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem’s IsletRx human stem cell-derived islets. Kadimastem’s IsletRx is a clinical-grade product candidate comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon. Dr. Anthony Japour, Chief Executive Officer of iTolerance, commented, “I believe that the feedback from the FDA is a critical milestone in the development of iTOL-102, and we are encouraged by their support for our innovative approach to treating Type 1 diabetes. We believe that the successful outcome of this meeting validates our commitment to bring a game-changing therapy to patients, one that could ultimately eliminate the need for chronic life-long immunosuppression. We look forward to continuing our collaboration with Kadimastem and working closely with the FDA.” Alex Zwyer, CEO of NLS, commented, “I believe that the news demonstrates the strength of the proposed merger of NLS and Kadimastem and its technology platform to build a healthy, strong merged company that will benefit shareholders.” Kadimastem Executive Chairman and CEO Ronen Twito said, "The promising results from the fast-track center for testing at the DRI, combined with the comprehensive studies conducted by iTolerance and Kadimastem, enabled us to complete this important milestone. We are working closely with the FDA on the necessary steps needed to implement this potential innovative technology for patients with Type 1 diabetes and demonstrate a novel islet cell transplantation approach with no need for immunosuppression.” About Kadimastem Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications. IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of the company and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST). About iTolerance, Inc. iTolerance is a regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic cadaveric and stem cell-derived pancreatic islet to potentially cure Type 1 diabetes. Utilizing iTOL-100 to induce local immune tolerance, the Company is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, the Company is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com. We are a clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, who have unmet medical needs. This press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS and Kadimastem are using forward-looking statements when they discuss the belief that the results of the pre-IND meeting with the FDA demonstrates the strength of the proposed merger; that the meeting with the FDA is a significant milestone in the development of iTOL-102, and the expected benefits of iTOL-102 in the treatment of diabetes. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastem and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: risks related to the companies’ ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the merger; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies’ products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; the companies’ patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or both of the companies; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of candidate products to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, neither Kadimastem nor NLS undertakes any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting NLS is contained under the heading “Risk Factors” in NLS’s annual report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”), which is available on the SEC’s website, www.sec.gov, and in subsequent filings made by NLS with the SEC, including under the heading “Risk Factors” in NLS’s registration statement on Form F-4, filed with the SEC on December 27, 2024. This press release may include forward-looking information as defined in the Securities Law, 5728 – 1968. Forward-looking information is uncertain and mostly is not under Kadimastem’s control and the realization or non-realization of forward-looking information will be affected, among other things, by the risk factors characterizing the company's activity, as well as developments in the general environment and external factors affecting the company's activity. The company's results and achievements in the future may differ materially from any presented herein and the company makes no undertaking to update or revise such projection or estimate and does not undertake to update this document. This press release does not constitute a proposal to purchase the company's securities or an invitation to receive such offers. Investment in securities in general and in the company in particular bears risks. One should consider that past performance does not necessarily indicate performance in the future. No Offer or Solicitation: This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Additional Information about the Transaction and Where to Find ItIn connection with the proposed transaction, NLS has filed a Registration Statement on Form F-4, including a proxy statement/prospectus, with the SEC. NLS may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or any other document that NLS may file with the SEC. The proxy statement (if and when available) will be mailed or delivered to shareholders of NLS and Kadimastem. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus (if and when available) and other documents containing important information about NLS and Kadimastem and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on NLS’s website at www.nlspharma.com. Participants in the Solicitation: NLS, Kadimastem, and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NLS and Kadimastem shareholders in respect of the proposed transaction. Information about the directors and executive officers of NLS, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in NLS’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, which was filed with the SEC on May 15, 2024. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger when such materials become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from NLS Pharmaceutics using the sources indicated above. Contact Details NLS Pharmaceutics Ltd. NLS Pharmaceutics Ltd. +41 44 512 21 50 contact@nls-pharma.com Kadimastem Ltd. Sarah Bazak +972 73-797-1615 s.bazak@kadimastem.com Company Website https://nlspharmaceutics.com/

February 25, 2025 07:00 AM Eastern Standard Time

Image
Article thumbnail News Release

NAVEX One: The Trusted Partner for NIS2 Risk Alignment

NAVEX Global

NAVEX, the global leader in integrated risk and compliance management software, is pleased to offer the first GRC solution to holistically address NIS2 across training, policies and assessment – all on one platform, NAVEX One. NAVEX continues to provide risk and compliance professionals with the tools they need to align with the latest cybersecurity regulations. As organizations face increasing regulatory demands, NAVEX One integrates policy management, training and risk assessment resources to ensure seamless compliance with the European Union’s Network and Information Security Directive (NIS2). The NIS2 Directive raises the bar for cybersecurity and reporting standards across industries, including banking, healthcare, manufacturing and energy. Organizations must not only comply with these heightened regulations but also ensure their cybersecurity frameworks are strong enough to withstand evolving threats. “NIS2 is a critical milestone in cybersecurity regulation, and organizations need a partner that helps them do more than just check the compliance box,” said A.G. Lambert, chief product officer at NAVEX. “NAVEX One empowers compliance and risk professionals to build a sustainable and proactive approach to cybersecurity, ensuring their programs are compliant and resilient against emerging threats.” NAVEX One serves as an essential tool in the journey toward risk and compliance maturity, helping organizations: Conduct proactive risk assessments to identify and mitigate vulnerabilities Centralize and streamline policy management to meet regulatory expectations Strengthen cybersecurity posture with comprehensive security awareness training Stay ahead of evolving cybersecurity requirements through continuous program improvement and board-ready reporting Extend training, policies and cyber risk practices to align third parties with its cyber risk standards “Organizations today require more than just static risk and compliance checklists—they need dynamic, integrated solutions that evolve with regulatory changes and emerging risks,” said Kyle Martin, vice president of risk solutions at NAVEX. “NAVEX One’s content and capabilities give businesses the confidence to proactively address NIS2 requirements while reinforcing their broader risk management strategies.” By integrating these capabilities within a single platform, NAVEX One simplifies compliance, reduces risk exposure, and supports organizations in building future-proof compliance programs. Click here, for more information on NAVEX One and the NIS2 Directive. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Navex Global scott.levesque@navex.com Company Website https://navex.com

February 18, 2025 12:50 PM Eastern Standard Time

Article thumbnail News Release

SBC Medical (NASDAQ: SBC) Announces New Translation App After Zacks & Sidoti Initiate Coverage, Emphasize Strong Growth

Benzinga

By Gerelyn Terzo, Benzinga With a potential Goldilocks setup in the economy being encouraged in part by a resilient consumer, the broader stock market was hovering near record territory toward the end of last year. Not to be outdone, healthcare-related companies have also been rallying, as evidenced by a gain of almost 20% in the S&P 500 Health Care Sector Index over the past 12 months. One of the stocks that has captured the attention of Wall Street of late is Tokyo-based SBC Medical Group (NASDAQ: SBC), a fast-growing service provider in the burgeoning medical aesthetics market that trades on Nasdaq. Most recently, Zacks Small-Cap Research (SCR) and Sidoti & Company have initiated coverage on the stock. In the October report, Zacks emphasized SBC Medical Group’s expansion efforts comprising both mergers and acquisitions, and organic growth, owing to a growing franchisee network and revenue base buttressed by a strong balance sheet. SBC Medical has been an early mover in Japan’s aesthetic medicine market, which according to the analyst firm, serves as a tailwind for future growth. Zacks SCR believes SBC Medical has “significant value.” Investors who are looking to back a leader in the medical innovation space can learn more about the opportunity in SBC Medical stock here. SBC Medical’s Growing Revenue Chief among the catalysts for the outlook in the report is SBC Medical’s strong reported revenue growth. The company’s revenue has been growing year-over-year, increasing from $174 million in 2022 to $194 million in 2023. Total revenues for the nine months ending Sep. 30, 2024 were $160 million, representing an increase of 23% from $131 million in the same period of 2023, SBC said. As a franchisor, SBC Medical has been growing its footprint amid a rising number of clinics in its vast network that contribute royalty revenue. In addition to Japan, the company also operates clinics in Los Angeles and Ho Chi Minh City, Vietnam, and has set its sights on a global expansion. SBC Medical is also operating in the black, reporting that with net income for the nine months ending Sep. 30, 2024 of $40.1 million, compared to $24.3 million in the same period of 2023. The company’s performance is being fueled by rising royalty income and other revenue streams with high gross margins, it says. Capitalizing On Medical Tourism For New Revenue Opportunities In 2025 The company has announced numerous initiatives to enhance its revenue streams in order to continue to grow its business both domestically and internationally. In January, SBC announced the launch of its proprietary translation app tailored for medical aesthetics staff and the full-scale implementation of its Inbound-Focused Clinics initiative. SBC says this move is designed to address the growing demand for medical tourism and to ensure that international patients can seamlessly experience Japan's advanced medical aesthetic treatments. Within Asia, rising awareness of aesthetic care and the increasing appeal of medical tourism are positioning countries like Japan, South Korea, and Thailand as top destinations for international patients, SBC notes. In Japan, the influx of foreign patients seeking high-quality medical aesthetics continues to rise. SBC alone says it welcomes over 10,000 inbound patients annually, with inquiries surpassing 20,000 each year. China remains a key market driver, though demand from English-speaking regions is also on the rise, the company says. Recognizing this trend, SBC says it is scaling up its operational capacity and implementing innovative solutions to support sustainable growth in this dynamic sector. Striving To Shift Communication With A Specialized Translation App To address language barriers, SBC has developed a translation app tailored specifically for medical aesthetics. It says the app ensures the accurate translation of specialized terminology, facilitating seamless communication between clinic staff and international patients. Currently supporting English and Chinese, the app plays a pivotal role in enabling smooth consultations and pre-treatment explanations. By creating a welcoming environment where language is no obstacle, SBC says it is empowering patients to feel secure and confident in their treatment choices. Future plans include expanding the app's language capabilities and rolling it out across all clinics nationwide, ensuring comprehensive accessibility for a global clientele, SBC noted. SBC Medical’s Valuation: Opportunities And Risks Zacks SCR pointed out that the medical aesthetic market is one that lacks direct competitors despite some companies offering similar services to SBC Medical. As a result, it is difficult to make apples-to-apples comparisons on the stock valuation as analysts typically do. In response, the Zacks analyst has taken a subset of the medical aesthetics space specializing in the healthcare sector to determine a fair valuation. The estimate is contingent upon the company executing on its growth plans as well as a broadening of its initiatives. Zacks SCR is encouraged by SBC Medical’s engagement with the industry, as evidenced by its participation in the Aesthetic Surgery and Laser Society (ASLS) aesthetic medicine conference in Korea held earlier this year. The firm also mentioned SBC Medical’s recently inked partnership with Tokyo-based technology provider B4A, which provides high-tech business solutions. SBC Medical’s mettle was tested amid a business combination with Pono Capital Two, a deal that was completed in Septemb er 2024, paving the way for the stock’s debut on Nasdaq. When it comes to investing, there are no sure things. Zacks SCR and Sidoti have also outlined potential risks that investors might consider. Among them is the uncertain nature of the wider aesthetic medical industry, which is heavily dependent on emerging technology for its growth. SBC’s international presence presents a foreign exchange risk since Its businesses are transacted in Japanese yen but translated into U.S. dollars for reporting purposes, a dynamic that has affected the company’s year-to-date financial performance in 2024. Investors who believe that the benefits outweigh the risks in SBC Medical’s stock can dive deeper into some of the company’s latest developments and offerings here. Featured photo by nattanan23 on Pixabay Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 07, 2025 08:35 AM Eastern Standard Time

Image
Article thumbnail News Release

Cognition Therapeutics Presents Phase 2 Results For Drug To Fight DLB At International Conference

Benzinga

By Meg Flippin, Benzinga Cognition Therapeutics, Inc. (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative disorders including dementia with Lewy bodies (DLB), had the opportunity to raise awareness about its experimental drug zervimesine (CT1812) when the company presented trial results in a podium presentation at the International Lewy Body Dementia Conference (ILBDC). The eighth International Lewy Body Dementia Conference, held in Amsterdam last week, drew an international audience of advocates, scientists and physicians looking for ways to fight this debilitating disease. Zervimesine is an experimental, orally delivered small molecule oligomer antagonist designed to treat this progressive form of dementia. Cognition Therapeutics recently reported positive topline results of its exploratory phase 2 SHIMMER study for the drug, announcing zervimesine produced strong therapeutic responses across behavioral, functional, cognitive and movement measures in patients with DLB. “Older adults with DLB are often placed in care facilities not because of memory issues, but due to the severity of neuropsychiatric or motor symptoms that overwhelm their caregivers,” said James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine, who was the study director for SHIMMER. “Patients on zervimesine had fewer cognitive fluctuations and showed better motor control than placebo-treated patients. The results from this exploratory phase 2 trial demonstrated zervimesine could have a meaningful, positive impact on DLB patients across multiple measures of cognitive, behavioral, movement and functional performance, potentially enabling people with DLB to live at home with the assistance of their care partners.” DLB Drug Holds Promise DLB is a progressive form of dementia characterized by symptoms that fluctuate in severity and can be difficult to diagnose early. It can cause people to have hallucinations, delusions and anxiety as well as cognitive declines that impair their thinking and reasoning. It can cause uncontrollable changes in alertness, sleep disruptions, tremors and slow movement. DLB impacts about 1.4 million people in the U.S. and is the costliest form of dementia. The double-blind, placebo-controlled phase 2 SHIMMER study had 130 adults enrolled who were evenly divided into groups that received either a placebo or a daily dose of zervimesine for six months. Cognition Therapeutics reported the study met its primary endpoint of safety and tolerability. As presented at ILBDC, zervimesine-treated DLB patients scored an average of 86% better than placebo-treated patients on the neuropsychiatric inventory (NPI) A-L at the end of the study. This tool describes the frequency and severity of 12 separate behavioral symptoms. The impact on the NPI scale in the SHIMMER trial means that patients receiving zervimesine had fewer or less severe hallucinations and delusions and less anxiety and agitation than placebo-treated patients, the company noted. These symptoms are a hallmark of DLB and can be debilitating for patients. The improvement in these behavioral symptoms was measured not only for patients but also their care partners, who reported improvements in their levels of distress caused by these symptoms. Patients, Caregivers Benefit From Zervimesine Patients who received zervimesine also preserved 52% more of their ability to care for themselves, measured by the activities of daily living (ADCS-ADL) scale, compared to those taking the placebo. Cognition said this was likely due to the improvements in behavioral symptoms as well as a 91% reduction in cognitive fluctuations in zervimesine-treated patients. Cognitive fluctuations are another hallmark of DLB and are described as a non-responsive state that can occur suddenly and last for hours. The person experiencing the fluctuation may or may not be aware that it is happening. On top of all that, the company said that based on trial results, zervimesine treatment allowed patients to maintain 62% better motor function – including gait, balance and tremors – than those on the placebo. “Dr. Galvin’s presentation is an important opportunity to educate an international audience of advocates, scientists and physicians about the impressive efficacy signals that were observed in participants treated with zervimesine (CT1812),” said Anthony O. Caggiano, MD, PhD, Cognition’s CMO and head of R&D. “The improvement we observed across behavioral, cognitive, functional and motor symptoms in zervimesine-treated participants suggest a broad and meaningful impact on their daily lives. These results reinforce zervimesine’s potential to address the complex and debilitating symptoms of this disease.” Featured photo by Pawel Czerwinski on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 06, 2025 09:00 AM Eastern Standard Time

Image
Article thumbnail News Release

New Prostate Cancer Hope? Bayer-Funded Phase 2 Study To Test Combination Of RedHill's Opaganib And Bayer’s Darolutamide, To Overcome Androgen Resistance

Benzinga

By Meg Flippin Benzinga It is often said that, “Prostate cancer is the cancer you die with, not because of,” but according to RedHill Biopharma (NASDAQ: RDHL), based on data published in Frontiers in Public Health, around 400,000 men a year worldwide would probably disagree with that statement. With global prevalence set to double to 2.9 million cases a year by 2040, early detection of prostate cancer (PC) often leads to a favorable outcome, with many patients thankfully responding very well to treatment. However, RedHill says around 20% of men with prostate cancer will either not respond to the current standard of care androgen receptor signaling inhibitor therapies, or will become resistant to these drugs, and will advance to a point where current treatments offer no additional hope. Patients who develop what is known as metastatic castrate-resistant prostate cancer (mCRPC) and are not responsive to hormone therapy, are left with virtually no treatment options. Invariably, they will go on to die from their cancer, the company says. But potentially, there may be some hope thanks to a clinical collaboration, funded by Bayer AG (ETR: BAYN), a large global pharma company, and the Ramsay Hospital Foundation, between RedHill, Bayer and Australian cancer researchers. The collaboration will involve a study to test the potentially enhancing effect of RedHill’s treatment, opaganib, in combination with Bayer’s darolutamide, in overcoming resistance to androgen receptor pathway inhibition (ARPI) treatment. First approved in 2021, and now approved in more than 80 countries, Bayer’s darolutamide was the fastest -growing androgen receptor blocker in the U.S. and continues to enjoy a strong growth trajectory, with sales in 2024 almost doubling 2023’s numbers. With more positive clinical data unveiled last year, and the expectation of additional approvals in more markets and across more prostate cancer indications, Bayer expects sales of darolutamide to peak at around $3 billion a year – potentially making it one of the most successful drugs in the prostate cancer space. Treating Advanced Stage Prostate Cancer A major driver of prostate cancer is androgen receptor signaling, which is why using chemical castration or androgen deprivation therapy has become a standard care treatment. Unfortunately, patients with advanced PC, and in particular those who have already progressed to mCRPC, become or are resistant to it, RedHill reports. However, the company also notes that according to the results of laboratory studies involving leading ARPI therapy, darolutamide, there may be a way to boost sensitivity to therapy and potentially overcome resistance – with the addition of another drug, opaganib. Opaganib is RedHill’s first-in-class, novel and orally-administered selective inhibitor of sphingosine kinase-2 (SPHK2). Opaganib has shown anti-inflammatory, anti-cancer and antiviral activity, and its mechanism of action, being an intracellular sphingolipid pathway modifier with multiple cell-level functions, including potential inhibition of tumor growth, supports the hypothesis that it could boost the efficacy of darolutamide, the company says. Cancer cells can block a cell-level process called apoptosis (programmed cell death), preventing the body from getting rid of unneeded or abnormal/unhealthy cells – a critical weapon our bodies use in fighting the spread of cancer. RedHill says prior research has shown that opaganib enhances androgen receptor signaling inhibitor efficacy in vitro through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS) and may potentially provide the key to overcoming darolutamide resistance in men with mCRPC. The company says, it is opaganib’s potential ability to induce metabolic stress in tumor cells that may be at the heart of the hope this study could bring people with mCRPC. With the prevalence of prostate cancer set to double over the next 15 years and only a 28% five-year relative survival rate in people with stage 4 prostate cancer, there is a significant need for new approaches in treating mCRPC patients. Pinpointing Who Is Most Likely To Benefit Patients with a poor prognosis due to ARPI resistance are most likely to benefit from an opaganib/darolutamide combination treatment approach, and identifying these patients will be key, RedHill says. As such, another innovation, a companion lipid biomarker test called PCPro, will be used to identify the right patients as part of the study. “Men with mCRPC have few treatment options available to them, and those positive for the PCPro marker of ARPI-resistance seem to have a particularly poor prognosis,” said Dr. Mark Levitt, RedHill’s chief scientific officer. “If the addition of opaganib can reduce the resistance to darolutamide therapy, this would represent a significant breakthrough in improving the ability to manage advanced treatment-resistant mCRPC for improved outcomes.” Phase 2 Trial Launching Soon Supported by Bayer and the Ramsay Hospital Foundation, the potential effectiveness of the opaganib/darolutamide combination will be put to the test in an 80-patient phase 2 clinical trial, due to start shortly. The placebo-controlled, randomized phase 2 study will evaluate the effect of opaganib, in combination with Bayer’s darolutamide, in overcoming resistance to standard-of-care androgen receptor pathway inhibition (ARPI) treatment in men with mCRPC who have not already received the newer AR signaling inhibitors such as enzalutamide, apalutamide, darolutamide or abiraterone. A primary endpoint of improved 12-month radiographic progression-free survival (rPFS) will be the key assessment of success in the study, but several secondary and exploratory endpoints will also be evaluated, the company noted. “The approach of developing therapeutic combinations and the companion lipid biomarker, PCPro, in parallel, is unique in metabolic targeting in metastatic prostate cancer, and this exciting study may provide proof of concept by testing the ability of sphingosine kinase-2 (SPHK2) inhibitors, such as opaganib, to overcome resistance to ARPI treatment,” said Professor Lisa Horvath, world-renowned prostate cancer researcher and chief clinical officer and director of research at Chris O’Brien Lifehouse. Sydney’s Chris O’Brien Lifehouse is a not-for-profit, comprehensive cancer hospital, that also developed the concept of using a PCPro marker-directed opaganib/darolutamide combination approach. “Cancer cells may block apoptosis (programmed cell death), an important cell-level process designed to help the body get rid of unneeded or abnormal/unhealthy cells – critical in fighting the spread of cancer,” Horvath said. Trial Partners Pedigree Australia is a global leader in the field, and the driving force behind this collaboration is Horvath and her team from Chris O’Brien Lifehouse. The trial will be led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Ltd. (ANZUP), a leading Cancer Cooperative Trials Group specializing in conducting studies for prostate, bladder, kidney, testicular and penile cancers. Prostate cancer diagnoses are expected to surge as the population around the world ages, and fighting this deadly disease just took on new urgency. If this combination of RedHill’s opaganib and darolutamide proves itself in this study, it may go on to play an important role in helping to improve the prospects for hundreds of thousands of men with advanced prostate cancer who currently have a very bleak outlook. Featured photo by National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

February 05, 2025 08:35 AM Eastern Standard Time

Image
Article thumbnail News Release

Biotech Investing: How PRVs Can Unlock Major Opportunities

Raz

In the world of biotechnology investing, companies often struggle to bring new drugs to market. Developing treatments for rare diseases can be incredibly expensive, and because these conditions affect relatively few patients, the financial payoff isn't always clear. To help incentivize drugmakers, the U.S. government created the Priority Review Voucher (PRV) program in 2007. PRVs act as a powerful tool that can significantly speed up the FDA approval process, making them a highly valuable asset—especially to major pharmaceutical companies. A PRV is awarded when a company gains approval for a drug that treats a rare pediatric disease (RPD), a tropical disease, or serves as a medical countermeasure for serious public health threats. Normally, FDA drug approvals take around 10 months, but using a PRV shortens that timeline to just six months. This four-month head start can be a game-changer, allowing companies to get a competitive edge or generate extra sales from blockbuster drugs. Since these vouchers don’t expire and can be freely bought and sold, they often end up in the hands of big pharmaceutical companies willing to pay top dollar for the advantage. PRV prices have historically hovered around $100 million, but with uncertainty surrounding the renewal of the rare pediatric disease PRV program, recent sales have surged past $150 million. If the program isn’t renewed, PRVs could become even scarcer, potentially driving prices even higher. Big pharma companies are fiercely competing for these vouchers, particularly in lucrative fields like obesity treatments, where shaving months off a drug’s approval timeline could mean capturing billions in market share. For small biotech companies, receiving a PRV can be a major financial boost. Take Day One Biopharmaceuticals (NASDAQ: DAWN) as an example. The company was awarded a PRV after its pediatric cancer drug, OJEMDA (tovorafenib), received FDA approval. Rather than using the voucher itself, Day One sold it for $108 million, securing much-needed funding without diluting shareholder value. This kind of transaction highlights why PRVs can be a game-changer for biotech firms—providing an immediate cash infusion that can support further drug development. With PRVs becoming an increasingly hot commodity, investors should keep an eye on biotech companies with potential voucher-earning drugs in development. With PRVs becoming increasingly valuable, several biotech companies could be next in line to benefit. Let’s take a look at three stocks with potential PRVs on the horizon. OS Therapies: OS Therapies (NYSE-A: OSTX) is emerging as a strong contender for a Priority Review Voucher (PRV), a potential game-changer for the company. The company is developing OST-HER2, an immunotherapy designed to prevent the spread of osteosarcoma (OS), a rare and aggressive bone cancer that primarily affects children and young adults. Because OS Therapies holds a Rare Pediatric Disease Designation (RPDD) from the FDA, an approval for OST-HER2 would make it eligible for a PRV—potentially bringing in around $150 million in non-dilutive funding. For a small biotech company, this is a game-changing opportunity. "The data we generated in our Phase 2b trial with OST-HER2 provides the first glimmer of hope in over 40 years that a paradigm shift could radically change the course of this deadly disease," said CEO Paul Romness. If OS Therapies secures FDA approval, not only would it mark a major breakthrough for osteosarcoma treatment, but the PRV could also provide the financial runway needed for future expansion. OS Therapies has already hit a key milestone, achieving the primary endpoint in its Phase 2b trial for OST-HER2. The treatment demonstrated a 33% Event-Free Survival (EFS) rate at 12 months, compared to just 20% in historical controls. Even more compelling, 91% of patients treated with OST-HER2 were alive at the one-year mark, versus 80% in the control group. These results indicate a significant improvement over existing treatment options, which have remained largely unchanged for decades. With these promising results in hand, OS Therapies plans to file for FDA approval (Biologics Licensing Application, or BLA) in late 2025, with potential approval by mid-2026. If successful, the company would receive a PRV just before the program sunsets, making it one of the last biotechs to benefit from this lucrative incentive. Financial Stability and Growth Potential Despite being a small-cap biotech, OS Therapies has positioned itself well financially. Over the past six months, the company raised $13.1 million through an IPO and a subsequent private placement. These funds are earmarked for final clinical trial payments, commercial manufacturing, and regulatory expenses—all crucial steps toward bringing OST-HER2 to market. Moreover, OS Therapies recently acquired key clinical assets from Ayala, including two additional Listeria-based immunotherapy candidates for lung and prostate cancer. This acquisition not only expands the company’s pipeline but also significantly reduces future cash obligations, improving long-term financial prospects. The Bigger Picture Beyond osteosarcoma, OST-HER2 has potential applications in other HER2-positive cancers, including breast cancer and canine osteosarcoma, where it has already received conditional approval from the U.S. Department of Agriculture. Additionally, the company is advancing its tunable Antibody Drug Conjugate (tADC) platform, a next-generation cancer therapy designed to improve targeted drug delivery. With multiple clinical programs, a solid financial strategy, and a real chance at securing a PRV, OS Therapies stands out as a compelling investment opportunity in biotech. If OST-HER2 gains FDA approval, the PRV could provide a significant financial boost—offering the company valuable resources for further development and creating substantial upside potential for investors. SpringWorks Therapeutics: SpringWorks Therapeutics (Nasdaq: SWTX) is a biotech company focused on developing treatments for severe rare diseases and cancer. Its first FDA-approved drug, OGSIVEO® (nirogacestat), treats desmoid tumors, but the company’s next major opportunity lies with mirdametinib—a drug currently in development for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), a rare condition that causes tumors to form along nerves. In the ReNeu trial, mirdametinib showed impressive results in both adults and children, reducing tumor size and improving pain and quality of life. Because of these promising outcomes, the FDA has granted Priority Review status to the drug, with a decision expected by February 28, 2025. If mirdametinib is approved, SpringWorks could earn a Priority Review Voucher (PRV), which would be a highly valuable asset for the company. A PRV allows for a faster approval process, providing a significant advantage for drugmakers. The company could choose to sell the PRV for a substantial financial boost, potentially funding future drug development or pipeline expansion without diluting shareholder value. With SpringWorks poised to potentially earn a PRV through mirdametinib, 2025 could be a pivotal year for the company, positioning it as a leader in rare disease treatments. Investors should keep a close eye on SpringWorks as it works toward FDA approval for mirdametinib and the possible PRV windfall. PTC Therapeutics PTC Therapeutics, Inc. (NASDAQ: PTCT) is a biopharmaceutical company dedicated to developing innovative treatments for rare diseases. The company has two important drugs that could earn PRVs in the near future, each representing a valuable opportunity for investors. First, vatiquinone, a drug for Friedreich ataxia (FA)—a rare, progressive disease that affects the nervous system—has been submitted for FDA approval. The company believes this drug could fill a big gap in treatment for both children and adults with FA, as there are very few options available right now. Vatiquinone has shown strong results in clinical trials, with evidence of slowing disease progression and improving quality of life. If approved, it could earn PTC a PRV, which could then be sold for a significant financial boost. The second drug, Sepiapterin, is being developed for phenylketonuria (PKU), a rare metabolic disorder that can cause serious developmental issues. PTC recently submitted Sepiapterin for FDA approval, based on promising trial results showing it can help patients manage the disease and even reduce their reliance on strict diets. If this drug gets FDA approval, it could also bring in a PRV for PTC, providing an additional source of funding. With two drugs in the pipeline that have the potential to earn PRVs, PTC Therapeutics is an exciting company to watch. These PRVs could provide significant financial support, helping the company continue its important work in rare disease treatments. Disclaimers: RazorPitch Inc. "RazorPitch" is not operated by a licensed broker, a dealer, or a registered investment adviser. This content is for informational purposes only and is not intended to be investment advice. The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions, or future events or performances are not statements of historical fact and may be forward-looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties that could cause actual results or events to differ materially from those presently anticipated. Forward-looking statements in this action may be identified through the use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements indicating certain actions & quote; may, could, or might occur. Understand there is no guarantee past performance will be indicative of future results. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or impaired due to the speculative nature of the companies profiled. RazorPitch has been retained and compensated by O S Therapies Inc to assist in the production and distribution of content related to OSTX. RazorPitch is responsible for the production and distribution of this content. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. This content is for informational purposes only; you should not construe any such information or other material as legal, tax, investment, financial, or other advice. Nothing contained in this article constitutes a solicitation, recommendation, endorsement, or offer by RazorPitch or any third-party service provider to buy or sell any securities or other financial instruments. All content in this article is information of a general nature and does not address the circumstances of any particular individual or entity. Nothing in this article constitutes professional and/or financial advice, nor does any information in the article constitute a comprehensive or complete statement of the matters discussed or the law relating thereto. RazorPitch is not a fiduciary by virtue of any persons use of or access to this content. Contact Details RazorPitch Mark McKelvie +1 585-301-7700 Mark@razorpitch.com Company Website http://razorpitch.com

February 05, 2025 07:00 AM Eastern Standard Time

12345 ... 256
News Direct Logo
Follow us on Facebook Follow us on LinkedIn
Get the latest from News Direct
Contact Us Pricing
Why News Direct
About us Features News Hub
Resources
Terms of Use Privacy Policy
newsdirect.com © 2025 News Direct Corp. All rights reserved. News Direct is a registered trademark.